Prostate CancerPhase 1NCT00946543
Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
A Phase 1 study testing hypofractionated radiation therapy and intensity-modulated radiation therapy in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- hypofractionated radiation therapy and intensity-modulated radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Mar 2000to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer meeting 1 of the following criteria:
- Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases
- Localized disease (stage pT2-T4) with > 30% estimated risk of pelvic nodal metastases
- High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN)
- Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement
- Candidate for radical radiotherapy
PATIENT CHARACTERISTICS:
- No inflammatory bowel disease or other small bowel disease
PRIOR CONCURRENT THERAPY:
- No prior pelvic radiotherapy or surgery (excluding prostatectomy)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Institute of Cancer Research - Chelsea
London, England, SW3 6JB
Contact Person, 44-20-7352-8133
- Recruiting
Institute of Cancer Research - Sutton
Sutton, England, SM2 5NG
Contact Person, 44-181-643-8901
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
David P. Dearnaley, MD, FRCP, FRCR, 44-20-8661-3271
About this study
Official title: A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.
Read the detailed description
OBJECTIVES:
- To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
- To determine the optimal dose level of this treatment regimen to be used in future studies.
OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume < 450 cc vs high small bowel volume ≥ 450 cc).
Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.
- Conditions
- Prostate Cancer
- Being tested
- hypofractionated radiation therapy, intensity-modulated radiation therapy
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiation therapyRadiation
intensity-modulated radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
Secondary outcomes (6)
Overall survival
Local control
PSA control
Acute side effects as assessed weekly by the RTOG scoring system
Quality of life
Patterns of recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startMar 2000
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- David P. Dearnaley, MD, FRCP, FRCR, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946543
- Sponsor's protocol ID
- CDR0000601695
- Other IDs
- RMNHS-1766, EU-20869
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Fernandez-Mateos J, Cresswell GD, Trahearn N, Webb K, Sakr C, Lampis A, Stuttle C, Corbishley CM, Stavrinides V, Zapata L, Spiteri I, Heide T, Gallagher L, James C, Ramazzotti D, Gao A, Kote-Jarai Z, Acar A, Truelove L, Proszek P, Murray J, Reid A, Wilkins A, Hubank M, Eeles R, Dearnaley D, Sottoriva A. Tumor evolution metrics predict recurrence beyond 10 years in locally advanced prostate cancer. Nat Cancer. 2024 Sep;5(9):1334-1351. doi: 10.1038/s43018-024-00787-0. Epub 2024 Jul 12.
PubMed 38997466
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00946543
- Acronym / sponsor ID
- CDR0000601695
- Conditions
- Prostate Cancer
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Mar 2010 (estimated)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.
Detailed description
OBJECTIVES:
- To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
- To determine the optimal dose level of this treatment regimen to be used in future studies.
OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume < 450 cc vs high small bowel volume ≥ 450 cc).
Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypofractionated radiation therapy | Radiation | – |
| intensity-modulated radiation therapy | Radiation | – |
Primary outcome
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
6 secondary outcomes
Overall survival
Local control
PSA control
Acute side effects as assessed weekly by the RTOG scoring system
Quality of life
Patterns of recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 38997466Fernandez-Mateos J, Cresswell GD, Trahearn N, Webb K, Sakr C, Lampis A, Stuttle C, Corbishley CM, Stavrinides V, Zapata L, Spiteri I, Heide T, Gallagher L, James C, Ramazzotti D, Gao A, Kote-Jarai Z, Acar A, Truelove L, Proszek P, Murray J, Reid A, Wilkins A, Hubank M, Eeles R, Dearnaley D, Sottoriva A. Tumor evolution metrics predict recurrence beyond 10 years in locally advanced prostate cancer. Nat Cancer. 2024 Sep;5(9):1334-1351. doi: 10.1038/s43018-024-00787-0. Epub 2024 Jul 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P. Dearnaley, MD, FRCP, FRCR principal investigator
Royal Marsden NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hypofractionated radiation therapy and intensity-modulated radiation therapy in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.